Status:

COMPLETED

Glutamine and Insulin Sensitivity in Type I Diabetes

Lead Sponsor:

Nemours Children's Clinic

Collaborating Sponsors:

Thrasher Research Fund

Conditions:

Type I Diabetes Mellitus

Eligibility:

All Genders

13-19 years

Phase:

NA

Brief Summary

Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sen...

Eligibility Criteria

Inclusion

  • Type I diabetes diagnosed for \> 12 months.
  • Minimal weight of 40 kg
  • Tanner stage IV or beyond
  • All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
  • HbA1C between 7.5 and 10%
  • BMI between 10th to 85th percentile
  • Patients on stable thyroid replacement therapy will be allowed to participate.

Exclusion

  • Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
  • Cystic Fibrosis
  • Chronic steroid therapy
  • Chronic medications that may interfere with glucose metabolism or liver function
  • History of mental retardation
  • Presence of diabetic complications
  • Positive pregnancy test
  • Presence of significant anemia (Hb\<11 g/dL)
  • Presence of intercurrent infection

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2013

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT01467063

Start Date

October 1 2011

End Date

July 1 2013

Last Update

July 14 2021

Active Locations (1)

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Nemours Children's Clinic

Jacksonville, Florida, United States, 32207